Corporate Events

Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The EV-303 study is evaluating PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS), the study’s primary endpoint, and overall survival (OS), a key secondary endpoint, with neoadjuvant and adjuvant PADCEV plus KEYTRUDA versus surgery alone. An additional secondary endpoint of pathologic complete response (pCR) rate was also met. The trial is continuing to evaluate the secondary EFS, OS and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature. The safety profiles for PADCEV plus KEYTRUDA and KEYTRUDA monotherapy were consistent with the known profiles of each treatment regimen Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally.i MIBC represents approximately 30% of all bladder cancer cases.ii The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival.ii However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone. Results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory filings. Neoadjuvant and adjuvant PADCEV plus KEYTRUDA is also being evaluated in cisplatin-eligible patients with MIBC in the EV-304 Phase 3 clinical trial (also known as KEYNOTE-B15). About the EV-303 Trial: The EV-303 trial is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA or neoadjuvant and adjuvant KEYTRUDA versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant KEYTRUDA (arm A), surgery alone (arm B) or neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA (arm C).

Astellas Pharma Inc. Presents at 13th Annual Immuno-Oncology Summit, Aug-11-2025 through Aug-13-2025. Venue: Philadelphia, Pennsylvania, United States. Presentation Date & Speakers: Aug-11-2025, Siddhartha Roychoudhury, Asset Leader, Immuno-Oncology Development.

Astellas Pharma Inc. announced that it has agreed on a memorandum of understanding ("MoU") with the Korea Institute of Startup and Entrepreneurship Development (President: Jong-pil Yoo, "KISED"), an umbrella organization of the Ministry of SMEs and Startups, a Korean Government Agency, for the operation of the partnership with Global Companies Program, which aims to identify Korean drug-discovery startups and support their business growth and global expansion. Under the terms of the MoU, KISED will provide overall management and research funding for the Partnership with Global Companies Program. Astellas will provide Korean drug-discovery startups, which are selected together, with KISED with access to laboratory and office space at SakuLabTM-Tsukuba, located on the premises of the Astellas Tsukuba Research Center. Startups residing in SakuLabTM-TSukuba will not only receive support through consultations with Astellas experts in various fields, but will also be able to accelerate their drug discovery research by leveraging networks with fellow residents and Astellas researchers. Through this program, two Korean pharmaceutical and biotech startups--TCUBEiT Inc. (a next-generation T-cell-based immunotherapy developer) and AAVATAR Therapeutics (specializing in AAV viral vector engineering technology-- have been selected. They will begin full-scale collaboration by moving into SakuLab™?-Tsukuba.

Astellas Pharma Inc. announced that they will report Q1, 2026 results at 3:30 PM, Tokyo Standard Time on Jul 30, 2025

Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis. For patients treated with XTANDI plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with XTANDI monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance. No new safety signals were observed in the analysis, and the safety results were consistent with the demonstrated safety profile of XTANDI. Among men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience BCR within 10 years. About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic prostate cancer. In the EMBARK study, patients were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. An initial analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. The most common adverse events (occurring in =10% of patients) in the combination group and the leuprolide-alone group were hot flashes and fatigue. The most common adverse events in the monotherapy group were gynecomastia, hot flashes, and fatigue.XTANDI is currently approved in more than 80 countries, including in the United States, European Union, and Japan.

Astellas Pharma Inc., Q1 2026 Earnings Call, Jul 30, 2025

Astellas Pharma Inc. Presents at SPACETIDE Japan 2025, Jul-10-2025 06:10 PM. Venue: Tokyo, Japan. Speakers: Reiko Wada, Senior Scientist.

SPACETIDE Foundation, SPACETIDE Japan 2025, Jul 07, 2025 through Jul 10, 2025. Venue: Tokyo, Japan.

IZERVAY Online Meeting

Astellas Pharma Canada Inc. announced that XTANDI®? (enzalutamide) is now funded by the Ontario Drug Benefit Program under the Exceptional Access Program for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence (BCR) at high risk of metastasis (high-risk BCR). This decision means XTANDI is now publicly reimbursed in Ontario for all of its approved prostate cancer indications. Health Canada granted Astellas market authorization for XTANDI in nmCSPC in January 2024. This approval was expedited as a result of XTANDI's inclusion in Project Orbis, an initiative of regulatory bodies, including Health Canada, with an aim to give patients faster access to promising cancer treatments in some countries around the world. The swift decision to reimburse XTANDI in Ontario is an important milestone towards making this important therapy available to Ontarians. Prostate cancer develops when abnormal cells form and grow in the prostate gland. nmCSPC describes the early stage of prostate cancer wherein the disease remains localized and still responds to medical or surgical treatment to lower testosterone levels. Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR), within 10 years. About XTANDI (enzalutamide) XTANDI is an androgen receptor (AR) inhibitor that overcomes resistance to conventional antiandrogens by inhibiting AR signaling at multiple steps in the pathway. XTANDI is approved for use in men in four prostate cancer disease states across five indications: The treatment of patients with non- metastatic castration-sensitive breast cancer (nmCSPC). The treatment of patients with non -metastatic castration- sensitive prostate cancer (nmCSPc). The treatment of patients with metastatic castration-sensitive prostate Cancer (mCSPC). The treatment the treatment of patients with non themetastatic castration-resistant prostate cancer (mCRPC). The treatment of metastatic castration- resistant prostate cancer (mCRPC) in patients: chemotherapy-naive and post-docetaxel. Please consult the Product Monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The product monograph is also available by calling Astellas Medical Information at 1-888-338-1824. XTANDI is a standard of care that has received regulatory approvals in more than 90 countries, including the United States, the European Union and Japan. Astellas is committed to supporting patients prescribed XTANDI through the XTANDI Patient Assistance Program by offering coverage coverage, financial assistance, patient and caregiver education as well as specialty pharmacy dispensing. Patients with a valid prescription prescription for the treatment of patients with high-risk BCR (p<0.0.0.0.1.0.0.0%.

Cambridge Healthtech Institute, Inc., 13th Annual Immuno-Oncology Summit, Aug 11, 2025 through Aug 13, 2025. Venue: Philadelphia, Pennsylvania, United States.

Astellas Pharma Inc. Presents at BIO International Convention 2025, Jun-16-2025 through Jun-19-2025. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States. Presentation Date & Speakers: Jun-17-2025, Andrew Mortlock, Executive Vice-President, Head of Early Development and Translational Science.

Mitsubishi Research Institute, Inc. and Astellas Pharma Inc. announced that they have agreed on a memorandum of understanding to provide drug-discovery startups in Japan with support in their efforts to go global. The pair aims to strengthen Japan's position as a global hub for drug discovery and foster the growth of its startups that can thrive globally. The new support represents multiple programs under the Ministry of Health, Labour and Welfare's Medical Innovation Support Office (MEDISO), which looks to address the lack of practical application of Japan's advanced life-sciences technologies. Mitsubishi Research Institute has been entrusted to operate MEDISO since 2018 and has been helping promising drug-discovery startups commercialize their intellectual property since. The new partnership looks to leverage the strengths of both companies. MRI will draw from its previous MEDISO work--supporting over twelve hundred startup and academic ventures--and design specific support programs for participants. Astellas Pharma will provide drug-discovery startups participating in the acceleration program conducted through MEDISO with access to laboratory and office space at SakuLab™?-Tsukuba, located on the premises of the Astellas Tsukuba Research Center. Startups residing in SakuLab™?- Tsukuba will not only receive support through consultations with Astellas experts in various fields, but will also be able to accelerate their drug discovery research by leveraging networks with fellow residents and Astellas researchers. The new support will provide Japanese drug-discovery startups with early access to pharmaceutical-industry insights, enabling them to chart a path toward successful global development and potential out-licensing. This aligns with the Basic Policy on Economic and Fiscal Management and Reform 2024, which aims to improve domestic research and development environments while encouraging the participation of global pharmaceutical companies and venture entrepreneurs in building a robust drug discovery ecosystem. Moving forward, MEDISO as a whole aims to collaborate with domestic and international business partners to support the global expansion of Japanese drug- discovery startups while encouraging global investors to invest in Japan's burgeoning drug discovery field.

The 20th term Annual Shareholders Meeting

Astellas Pharma Inc. and Pfizer Inc. announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES (NCT02677896) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDItm (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Such factors include, but are not limited to: changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the ability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. R risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the EMBARK trial will meet the secondary endpoint of overall survival; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for XTANDI may be filed in other jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for XTANDI (including the application pending with the European Medicines Agency), which will depend on a myriad of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether XTANDI for any potential indication will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of XTANDI, including for the new indication; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

Astellas Pharma Inc. will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3). (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysis. EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in J. Bedke Type: Poster Presentation combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma. Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab Vedotin plus S. Gupta Type: Oral Presentation combination with pembrologyizumab vs chemotherapy (chemo) in previously untreated locally advanced or prostate urothelial carcinoma; Evaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and M. Galsky Type: Poster Presentation meta-analysis; Study EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedot monotherapy in N. Mar Type: Poster Presentationcisplatin-ineligible patients with muscle-invasive bladder cancer; 3-year efficacy results. Recent trends in US real-world first-line treatment patterns for patients with locally advanced G. Sonpavde Type: E-Publication Only or metastatic urothelal carcinoma. Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous E. Theodorou Type: E-Publication only cell carcinoma and its treatment.

Astellas Pharma Inc., Board Meeting, May 15, 2025. Agenda: To consider the Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme and Performance-linked Stock Delivery Scheme for the Domestic and Global Astellas Group Executives.

Astellas Pharma Inc., Board Meeting, May 07, 2025. Agenda: To consider and a change in Directors as outlined; and to discuss other matters.

Astellas Pharma Inc. Presents at ARVO 2025 Annual Meeting, May-04-2025 through May-08-2025. Venue: Calvin L. Rampton Salt Palace Convention Center, Salt Lake City, Utah, United States. Presentation Date(s): May-04-2025. May-05-2025. May-06-2025. May-07-2025.

Astellas Pharma Inc. Presents at Retina World Congress 2025, May-08-2025 through May-11-2025. Venue: Marriott Harbor Beach Resort, Fort Laurderdale, Florida, United States. Presentation Date & Speakers: May-08-2025, Jake Schumacher, VP, US Head of Izervay. May-09-2025.

Healio LIVE, Canadian Energy Explorers and Producers Investment Conference, Retina World Congress 2025, May 08, 2025 through May 11, 2025. Venue: Marriott Harbor Beach Resort, Fort Laurderdale, Florida, United States.

Astellas Pharma Inc., Annual General Meeting, Jun 19, 2025.

Astellas Pharma Inc. expected to report Q1 2026 results on July 30, 2025. This event was calculated by S&P Global (Created on July 10, 2025).

Astellas Pharma Inc. Presents at Cell & Gene Meeting on the Med 2025, Apr-15-2025 . Venue: Rome Cavalieri - A Waldorf Astoria Hotel, Rome, Italy.

Astellas Pharma Inc. Presents at Cell & Gene Meeting on the Med 2025, Apr-15-2025 through Apr-17-2025. Venue: Rome Cavalieri - A Waldorf Astoria Hotel, Rome, Italy. Presentation Date & Speakers: Apr-15-2025, Richard Wilson, Senior Vice President, Primary Focus Lead. Apr-16-2025.

Astellas Pharma Inc., 2025 Earnings Call, Apr 25, 2025

Astellas Pharma Inc. announced that they will report fiscal year 2025 results on Apr 25, 2025

Astellas Pharma Inc. Presents at Adobe Summit 2025, Mar-17-2025 . Venue: The Venetian Convention and Expo Center, Las Vegas, Las Vegas, United States. Speakers: Madan Rajavel, Global Adobe Experience Platforms Lead, Nicolas Barcza, Global Web Activation Lead.

Diversified Communications, Llc, IOFM Spring Conference 2025, May 12, 2025 through May 14, 2025. Venue: Orlando, Florida, United States.

Astellas Pharma Inc. and YASKAWA Electric Corporation signed a definitive agreement to establish a joint venture for the development of a cell therapy product manufacturing platform utilizing the dual-arm robot "Maholo." In addition, the joint venture will offer platform access to startups and academic institutions, fostering collaboration and innovation in the field of cell therapy. In the pharmaceutical industry, the commercialization of cell therapy faces many challenges stemming from the complex nature of the manufacturing process, in particular, related to the accuracy and reproducibility of cell manufacturing. Furthermore, the need for a skilled workforce, coupled with the time and cost investments required for technology transfer to manufacturing facilities, presents additional hurdles. Based on the memorandum of agreement signed in May, 2024, Astellas and YASKAWA have been advancing discussions toward establishing a joint venture to leverage their mutual strengths and accelerate efforts to address these challenges. The planned joint venture will leverage Astellas' expertise in R&D and manufacturing for cell therapy and the dual arm robot "Maholo," developed by YASKAWA's subsidiary, Robotic Biology Institute. The closing and establishment of the joint venture company are subject to certain closing conditions, including receipt of required regulatory approvals.

Astellas Pharma Inc. Presents at Global Life Science Partnering and Investor Conference, Feb-26-2025 08:30 AM. Venue: THE LODGE AT TORREY PINES, LA JOLLA, California, California, United States. Speakers: Issei Tsukamoto, SVP, Head of Business Development.

Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a result, IZERVAY is now approved without a limitation on duration of dosing—providing physicians and patients with greater flexibility when managing GA. The approval follows Astellas' resubmission of the supplemental New Drug Application (sNDA) for IZERVAY on December 26, 2024, within days of meeting with the FDA to clarify the Agency's feedback provided in the Complete Response Letter (CRL) issued in November 2024. The approved label update was based on positive results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of IZERVAY through year 2. Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Post-marketing safety reporting remains consistent with that observed in the clinical trial program, with no new or significant safety signals identified, providing confidence to prescribers in IZERVAY's safety profile. The GATHER2 study demonstrated that IZERVAY continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. The treatment benefit with IZERVAY versus sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1. IZERVAY was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over 2 years, the incidence of choroidal neovascularization was slightly increased between IZERVAY (11.6%) versus sham (9%). IZERVAY was approved by the U.S. Food and Drug Administration on August 4, 2023, for the treatment of GA secondary to AMD. The impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor.

Pfizer Inc. and Astellas Pharma Inc. announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months). These data will be presented during a rapid oral session (Abstract 664) at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025 in San Francisco, CA, on February 14, 2025. Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy (hazard ratio [HR] = 0.51, 95% confidence interval [CI], 0.43-0.61). The median OS was 33.8 months for the combination versus 15.9 months for chemotherapy. The OS benefit was observed in all prespecified subgroups, including cisplatin eligible and ineligible subgroups. Enfortumab vedotin plus pembrolizumab also reduced the risk of disease progression or death by 52% versus chemotherapy (HR = 0.48, 95% CI, 0.41-0.57). The median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy. The safety profile was consistent with previous findings and no new safety concerns were identified. In addition to longer follow-up data, an exploratory analysis evaluating treatment outcomes and safety profile in patients with confirmed complete response (cCR) will also be presented. Among patients evaluable for response, confirmed objective response rate (cORR) was 67.5% for enfortumab vedotin plus pembrolizumab compared to 44.2% for chemotherapy. Median duration of response (DOR) was 23.3 months (95% CI, 17.8-not estimable [NE]) for the combination and 7.0 months (95% CI, 6.2-9.0) for chemotherapy. A cCR was achieved in 30.4% of patients treated with enfortumab vedotin plus pembrolizumab and 14.5% of patients treated with chemotherapy. Median duration of cCR was not reached for the combination and 15.2 months (95% CI, 10.3-NE) for chemotherapy. In patients with cCR, grade =3 treatment-related adverse events occurred in 61.7% of patients in the enfortumab vedotin plus pembrolizumab arm compared to 71.9% in the chemotherapy arm. There were no treatment-related deaths in the cCR subgroup.

Astellas Pharma Inc. announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for Conditional Approval of avacincaptad pegol intravitreal solution (ACP), a synthetic aptamer that inhibits the complement C5 protein, for the treatment of GA secondary to AMD. If approved, ACP has the potential to become the first and only GA treatment available in Japan. GA is a progressive form of AMD that can cause irreversible vision loss, with no treatments currently approved outside the US or Australia. Globally, over five million people are estimated to have GA and, without timely treatment, an estimated 66% of people living with GA may become legally blind or severely visually impaired. As a result, GA secondary to AMD has a substantial impact on patients' daily lives and psychological wellbeing. The NDA submission is based on results of overseas clinical trials, including the GATHER1 and GATHER2 randomized, sham-controlled clinical trials, which evaluated the safety and efficacy of monthly 2mg intravitreal administration of ACP in patients with GA secondary to AMD. The data from both trials demonstrates that ACP slows GA lesion growth and has a favorable safety profile.Sustained efficacy of ACP, as shown in the restriction of lesion growth over time, was observed over a follow up of two years in GATHER1 and GATHER2 studies. This submission will have no impact on the financial forecasts of the current fiscal year ending March 31, 2025.

Astellas Pharma Inc. announced that the following changes to its management structure effective April 1, 2025. Astellas aims to create and deliver "VALUE" for patients. To promote drug discovery activities swiftly and efficiently from the early stages of research through to commercialization with patient-centric approach, Astellas will change its management structure effective April 1, 2025, establishing new top management positions and making personnel changes as follows: Establishment and Appointment of Chief Research & Development Officer (CRDO): As an innovation engine, the company will integrate the research and development teams, and the Primary Focus Leads to provide the next-generation groundbreaking therapies from Astellas. Effective April 1, 2025, the company will establish the position of CRDO, overseeing these divisions, with Tadaaki Taniguchi, M.D., Ph.D., the current Chief Medical Officer (CMO), appointed to this role. Establishment and Appointment of Chief Commercial & Medical Affairs Officer (CCMAO): To build customer engagement that leads the pharmaceutical industry, the company will integrate the current Commercial and Medical Affairs functions while maintaining the independence of each function. Effective April 1, 2025, the company will establish the position of CCMAO, overseeing these divisions, with Claus Zieler, the current Chief Commercial Officer (CCO), appointed to this role. With this change in management structure, the roles of CMO, CCO, and Chief Scientific Officer (CScO) will be eliminated. Yoshitsugu Shitaka, Ph.D., the current CScO, will resign effective March 31, 2025. Appointment of Chief Manufacturing Officer (CMfgO): Rao V. Mantri, Ph.D. will be appointed to the new CMfgO, as of April 1, 2025. He joined Astellas on February 3, 2025, and has extensive experience in a global pharmaceutical company, focusing on innovation in product development, manufacturing, and supply, as the companyll as being involved in management. Hideki Shima, the current CMfgO, will resign effective March 31, 2025. Establishment and Appointment of General Counsel and Chief Ethics & Compliance Officer (GC & CECO): will consolidate legal, intellectual property, quality assurance, and ethics & compliance into a single top management position as an important risk management function. Effective April 1, 2025, company will establish the position of GC & CECO, with Tatjana Dragovic appointed to this role. Since joining Astellas in 2007, she has held leadership roles in legal and ethics & compliance. Catherine Levitt, the current GC, will resign effective March 31, 2025. Top Management (Effective April 1, 2025): Name and Title: Naoki Okamura, Representative Director, President and Chief Executive Officer (CEO); Katsuyoshi Sugita, Representative Director, Corporate Executive Vice President, Chief People Officer (CPO); Tadaaki Taniguchi, Chief Research & Development Officer (CRDO); Rao Mantri, Chief Manufacturing Officer (CMfgO); Claus Zieler, Chief Commercial & Medical Affairs Officer (CCMAO); Adam Pearson, Chief Strategy Officer (CStO); Nick Eshkenazi, Chief Digital & Transformation Officer (CDTO); Atsushi Kitamura, Chief Financial Officer (CFO); Tatjana Dragovic, General Counsel and Chief Ethics & Compliance Officer (GC & CECO).

Alliance for Regenerative Medicine, Cell & Gene Meeting on the Med 2025, Apr 15, 2025 through Apr 17, 2025. Venue: Rome Cavalieri - A Waldorf Astoria Hotel, Rome, Italy.

Astellas Pharma Inc. Presents at 6th RAS-Targeted Drug Development Summit, Sep-26-2024 12:15 PM. Venue: Revere Hotel Boston Common, 200 Stuart Street, Boston, Massachusetts, United States. Speakers: Chinatsu Sakata, Primary Focus Lead of Targeted Protein Degradation.

Astellas Pharma Inc. Presents at World CDx & LBx Summit APAC, Nov-13-2024 12:30 PM. Venue: Conrad Centennial, 2 Temasek Blvd, Singapore , Singapore. Speakers: Janise Chevrier-Lee, Regional Medical Director, International Markets and China.

Astellas Pharma Inc. Presents at 6th Gene Therapy Analytical Development & CMC Summit, Oct-30-2024 01:00 PM. Venue: The Westin Copley Place, 10 Huntington Ave, Boston, Massachusetts, United States. Speakers: Irene Kwan, Research Associate, Luis Rascon, Research Associate II, Analytical Development, Sue Duan, Head of Analytical Development.

Astellas Pharma Inc. Presents at 2024 APAC Commercial Summit, Sep-10-2024 . Venue: Marina Bay Sands, Singapore, Marina Bay, Singapore. Speakers: Arti Dhar, Medical Lead, Oncology, International Markets & China Region.

Astellas Pharma Inc. Presents at 5th Annual Dry AMD & GA Therapeutics Summit, Oct-29-2024 09:00 AM. Venue: Hilton Boston Back Bay, 40 Dalton St, Boston, Massachusetts, United States. Speakers: Dang Dao, Director.

Astellas Pharma Inc. Presents at Veeva R&D and Quality Summit, Oct-31-2024. Venue: Tokyo, Japan. Presentation Date & Speakers: Oct-31-2024, Toshinori Tsuzuki, Regulatory Affairs Department, Toshiyuki Okada, Clinical Development Clinical Operational Excellence.

Sustainability Meeting 2024

Astellas Pharma Inc. Presents at Biotech Showcase 2025, Jan-13-2025 through Jan-15-2025. Venue: Hilton San Francisco, Union Square (Yosemite C), San Francisco, California, United States. Presentation Date & Speakers: Jan-13-2025, Adam Pearson, Chief Strategy Officer, Tadaaki Taniguchi, Senior Executive Officer & Chief Medical Officer.

Astellas Pharma Inc. Presents at BIO Partnering @JPM Week, Jan-13-2025 . Venue: San Francisco Marriott Marquis, San Francisco, California, United States.

Astellas received Health Canada approval for VYLOY® (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer. VYLOY is the first and only therapy approved in Canada totarget claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer1,2; Treatment with VYLOY shown to significantly extend both progression-free survival and overall survival in Phase 3 trials. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38% of patients screened had tumours that were CLDN18.2 positive, defined as 75% of tumour cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using an in-vitro companion diagnostic test or medical device. As an investigational first-in-class monoclonal antibody (mAb), zolbetuximab targets and binds to CLDN18.2, a transmembrane protein expressed on cancer cells. In pre-clinical studies, zolbetuximab reduced the number of CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to tumour growth inhibition. Data from the Phase 3 SPOTLIGHT and GLOW clinical trials, which supported Health Canada's authorization, showed that treatment with zolbetuximab provided statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to the standard of care chemotherapies in eligible patients with gastric or GEJ cancers. In the SPOTLIGHT trial, a median PFS of 10.61 months was achieved with zolbetuximab plus mFOLFOX6 as first-line treatment, versus 8.67 months with placebo plus mFOLFOX6. The median OS was 18.23 months versus 15.54 months in the respective treatment groups.1 Similar efficacy findings were seen in the GLOW trial where median PFS was 8.21 months versus 6.80 months, and median OS 14.39 months versus 12.16 months, with zolbetuximab plus CAPOX, compared to placebo plus CAPOX, respectively.2 In both the SPOTLIGHT and GLOW trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite. This regulatory approval for zolbetuximab follows the October 2024 approval by the U.S. FDA, the September 2024 approval by the European Commission (EC), the August 2024 approval by the UK Medicines and Healthcare products Regulatory Agency, and the March 2024 approval by Japan'sMinistry of Health, Labour and Welfare. Astellas has submitted further applications for zolbetuximab to other regulatory agencies around the world with reviews ongoing.About VYLOY (Zolbetuximab) Zolbetuximab is a claudin 18.2-directed cytolytic antibody that was investigated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38 per cent of patients screened had tumours that were CLDN18.2 positive, defined as =75 per cent of tumour cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using an in-vitro companion diagnostic test or medical device. As an investigational first-in-class monoclonal antibody (mAb), zolbetuximab targets and binds to CLDN18.2, a transmembrane protein expressed on cancer cells. In pre-clinical studies, zolbetuximab reduced the number of CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to tumour growth inhibition. About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer Gastric and gastroesophageal junction (G/GEJ) cancers are known to be histologically similar, are recommended to be managed in the same way in treatment guidelines, and frequently display aligned responses to treatment. Gastric cancer (GC) is the fifth most common cancer and the fourth leading cause of cancer-related deaths worldwide. In Canada, there were approximately 4,100 new cases in 2023, with an incidence rate of 8.6 per 100,000 people.GEJ adenocarcinomas start in the first two inches (5 cm) where the esophagus joins the stomach. GC has a 5-year survival rate of 29 percent in Canada, driving the need for new therapeutic options that can slow disease progression and extend lives.Because early-stage cancer symptoms frequently overlap with more common stomach-related conditions, G/GEJ cancers are often diagnosed in the advanced or metastatic stage, or once they have spread from the tumour's origin to other body tissues or organs.Early signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, bloating of the stomach after meals, loss of appetite. Signs of more advanced G/GEJ cancer can include unexplained weight loss, weakness and fatigue, sensation of food getting stuck in the throat while eating, vomiting blood or having blood in the stool. Risk factors associated with G/GEJ cancer can include older age, male gender, family history, H. pylori infection, smoking, and gastroesophageal reflux disease (GERD).INVESTIGATIONAL STUDIES About the SPOTLIGHT Phase 3 Clinical Trial SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumours were CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint is progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters.

Hanson Wade Limited, 6th Gene Therapy Analytical Development & CMC Summit, Oct 30, 2024 through Nov 01, 2024. Venue: The Westin Copley Place, 10 Huntington Ave, Boston, Massachusetts, United States.

Astellas Pharma Inc. Presents at Longwood Healthcare Leaders Stanford Summit, Jan-11-2025 through Jan-12-2025. Venue: Four Seasons Hotel San Francisco, 757 Market Street, San Francisco, California, United States. Presentation Date & Speakers: Jan-12-2025, Richard Wilson, SVP, Primary Focus Lead, Tadaaki Taniguchi, Senior Executive Officer & Chief Medical Officer.

Longwood Fund, Longwood Healthcare Leaders Stanford Summit, Jan 11, 2025 through Jan 12, 2025. Venue: Four Seasons Hotel San Francisco, 757 Market Street, San Francisco, California, United States.

Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025, in response to the Agency's November 2024 Complete Response Letter (CRL). The application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period. A target action date has been set for February 26, 2025. IZERVAY was approved by the U.S. food and Drug Administration on August 4, 2023, for the treatment of GA secondary to AMD. The sNDA seeks to add positive 2-year data to the IZERVAY U.S. Prescribing Information based on results from the GATHER2 Phase 3 clinical trial. IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD). IZERVAY can cause serious side effects: Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Call healthcare provider right away if have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in vision, flashes of light, or increased sensitivity to light. There is a risk of developing wet AMD with IZERVAY. Should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to healthcare provider to monitor. IZERVAY may cause a temporary increase in eye pressure after the injection.

Astellas Pharma Inc. announced that China'sNational Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). The treatment combination will provide a new therapeutic option to patients with la/mUC in China and offer an alternative to platinum-containing chemotherapy, the standard of care for nearly 40 years. Bladder cancer leads to significant morbidity and mortality across China. Over 92,000 people were diagnosed with bladder cancer in 2022, and approximately 41,000 deaths were reported as a result of the disease. Urothelial cancer, which accounts for 90% of all bladder cancers, is a debilitating and frforequently aggressive cancer. When the disease is diagnosed at a late stage, survival rates are often extremely poor, driving the urgent need for new treatment strategies that can extend patients' lives. The NMPA's approval of enfortumab vedotin in combination with pembrolizumab is supported by the results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial demonstrated that the treatment combination improved median overall survival (OS) and median progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. A median OS of 31.5 months (95% CI: 25.4-NR) was achieved with the treatment combination compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). A median PFS of 12.5 months (95% CI: 10.4-16.6) was reported with the treatment combination compared to 6.3 months (95% CI: 6.2-6.5) with platinum-containing chemotherapy, representing a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). The safety results were consistent with those previously reported with this treatment combination, and no new safety issues were identified.

Astellas Pharma Inc., Q3 2025 Earnings Call, Feb 04, 2025

Astellas Pharma Inc. announced that China'sNational Medical Products Administration has approved VYLOY (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive. Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment. Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported from the disease in 2022.5 As early symptoms are often hard to detect, approximately 60% of Chinese patients are diagnosed at the advanced stage of the disease where treatment options are limited and outcomes are often poor. The average five-year survival rate for patients with advanced gastric cancer in China is 9.1%, driving the urgent need for novel therapeutic options that can slow disease progression and extend lives. The NMPA's approval of zolbetuximab is supported by data from the global Phase 3 GLOW and SPOTLIGHT clinical trials which included 145 and 36 patients from mainland China, respectively. The GLOW trial evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX. The SPOTLIGHT trial evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. Treatment with zolbetuximab was shown to provide statistically significant improvements in progression-free survival and overall survival compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers. In the GLOW trial, a median PFS of 8.21 months was achieved with zolbetuximab plus CAPOX as first-line treatment versus 6.80 months with placebo plus CAPOX. The median OS was 14.39 months versus 12.16 months in the respective treatment groups. Similar efficacy results were seen in the SPOTLIGHT trial, where the median PFS was 10.61 months versus 8.67 months, and the median OS was 18.23 months versus 15.54 months, with zolbetuximab plus mFOLFOX6, compared to placebo plus mFOLFOX6. In both the GLOW and SPOTLIGHT trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite. Astellas has already reflected the impact from the NMPA approval of zolbetuximab in its financial forecast for the current fiscal year ending March 31, 2025.

Astellas Pharma Inc. announced that they will report Q3, 2025 results on Feb 04, 2025

Astellas Pharma Inc. expected to report Fiscal Year 2025 results on April 25, 2025. This event was calculated by S&P Global (Created on January 3, 2025).

Astellas Pharma Inc. has completed a Fixed-Income Offering in the amount of ¥80 billion. Security Name: 0.87% Unsecured Notes due September 07, 2029 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: ¥80 billion Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Astellas Pharma Inc. has completed a Fixed-Income Offering in the amount of ¥20 billion. Security Name: 1.038% Unsecured Straight Bonds due September 09, 2031 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: ¥20 billion Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Astellas Pharma Inc. has announced a Fixed-Income Offering in the amount of ¥20 billion. Security Name: 1.038% Unsecured Straight Bonds due September 09, 2031 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: ¥20 billion Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Sangamo Therapeutics, Inc. and Astellas Pharma Inc. announced they have entered into a license agreement allowing Astellas to leverage Sangamo's novel proprietary neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, which has demonstrated potent blood-brain barrier penetration andonal transduction in nonhuman primates. The agreement grants Astellas a worldwide exclusive license to utilize the STAC-BBB capsid for one target, with the right to add up to four additional targets after paying additional licensed target fees to deliver their intravenously administered genomic medicines to treat certain neurological diseases. Under the terms of the agreement, Sangamo is responsible for completing a technology transfer related to the STAC-BBB capid. Astellas is responsible for all research, preclinical and clinical development, regulatory interactions, manufacturing, and global commercialization of the resulting gene therapy products. Sangamo will receive a $20 million upfront license fee from Astellas and is eligible to earn up to $1.3 billion in additional licensed target fees and milestone payments across the five potential neurology disease targets, as well as tiered mid-to-high single digit royalties on potential net sales of such products, subject to certain specified reductions.

Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on November 15, 2024, regarding the supplemental New Drug Application (sNDA) for IZERVAYTM (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The sNDA sought to include positive two-year data in the U.S. Prescribing Information for IZERVAY based on results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly (EM) and every other month (EOM) dosing through year 2. The FDA stated the agency cannot approve the sNDA in its present form by the Prescription Drug User Fee Act (PDUFA) action date of November 19, 2024. The FDA comments outlined in the CRL are unrelated to the benefit/risk of the use of IZERVAY; rather, the comments focus on a statistical matter related to labelling language proposed by Astellas. Astellas is seeking further clarification from the FDA and looks forward to working with the agency to quickly address the agency's feedback.

Astellas Pharma Inc. expected to report Q3 2025 results on January 31, 2025. This event was calculated by S&P Global (Created on November 2, 2024).

Astellas Pharma Inc. Presents at ICR Healthcare's 12th Annual Healthcare Conference, Nov-18-2024 01:05 PM. Venue: London, United Kingdom. Speakers: Elena Cavalli, Head of Commercial & Enterprise alliances, Business Development.

Astellas Pharma Inc., ¥ 37.0, Cash Dividend, Mar-28-2025

Astellas Pharma Inc. Presents at BIO-Europe 2024, Nov-04-2024 02:00 PM. Venue: Stockholmsmässan, Stockholm, Sweden. Speakers: Elena Cavalli, Head of Commercial & Enterprise Alliances, Business Development.

Astellas Pharma Inc. Presents at World Drug Safety Congress US, Oct-30-2024 09:25 AM. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States. Speakers: Lena Mishalov, Executive Director, Head of PV Transformation and Technology.

Astellas Pharma Inc. Presents at 4th Annual Clinical Trial Innovation Summit, Oct-22-2024 03:20 PM. Speakers: Janet Moga, DCT Operations Lead.

Astellas Pharma Inc., Q2 2025 Earnings Call, Oct 30, 2024

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S. In the SPOTLIGHT and GLOW clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive. CLDN18.2 positivity is defined as =75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, as determined by the VENTANA CLDN18 (43-14A) RxDx Assay from Roche. Astellas collaborated with Roche on the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who may be eligible for VYLOY. The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated VYLOY plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated VYLOY plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX. Both trials met their primary endpoint, progression-free survival (PFS), as well as a key secondary endpoint, overall survival (OS), in patients treated with VYLOY plus chemotherapy compared to placebo plus chemotherapy. Across the SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse events (TEAEs) reported in the VYLOY treatment arms were nausea, vomiting and decreased appetite. An FDA-approved test is used to identify patients who may be eligible for VYLOY. The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status. Testing is available in the U.S. at multiple reference laboratories nationwide and is expected to expand to additional laboratories over time.

Biotechnology Innovation Organization, BIO International Convention 2025, Jun 16, 2025 through Jun 19, 2025. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States.

Astellas Pharma Inc. announced that they will report Q2, 2025 results at 3:00 PM, Tokyo Standard Time on Oct 30, 2024

Astellas Pharma Inc. Presents at 2024 Cell & Gene Meeting on the Mesa, Oct-07-2024 through Oct-09-2024. Venue: Arizona Biltmore, FLW, 2400 E Missouri Ave, Phoenix , Arizona, United States. Presentation Date & Speakers: Oct-07-2024. Oct-08-2024, Yoshitsugu Shitaka, Chief Scientific Officer & Senior Managing Executive Officer. Oct-09-2024, Richard Wilson, Senior Vice President, Primary Focus Lead, Genetic Regulation.

Astellas Pharma Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEVTM (enfortumab vedotin [genetical recombination]) with MSD's KEYTRUDA (pembrolizumab [genetical recombination]) as a combination therapy for the first-line treatment of adult patients with radically unresectable urothelial carcinoma. This is the first approved combination treatment for radically unresectable urothelial carcinoma in Japan to offer an alternative to platinum-containing chemotherapy, the current standard of care for first-line treatment. In Japan, bladder cancer is the 9 most common cancer, with over 34,500 new cases diagnosed and 11,000 deaths reported from the disease in 2022. Particularly poor outcomes are associated with the latter stages of the disease, with global five- year survival rates of 39% and 8% for locally advanced and metastatic urothelial cancer, respectively. The approval by the MHLW was supported by results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median overall survival of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with platinum- containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). The median progression-free survival of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). The safety results in EV-302 are consistent with those previously reported for this combination in EV-103 in cisplatin-ineligible patients with la/mUC. The most common (3%) Grade 3 or higher adverse events (AEs) related to treatment with enfortumab vedotin in combination with pembrolizumab were maculo- papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. No new safety issues were identified. During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice.1 Results were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.

Astellas Pharma Inc. announced that the European Commission (EC) has approved VYLOY (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. The European Medicines Agency has recommended that zolbetuximab's designation as an orphan medicinal product be maintained in recognition of the poor survival outcomes associated with gastric and GEJ cancers. Zolbetuximab is currently the first and only approved monoclonal antibody specifically designed to target gastric tumor cells that express the biomarker CLDN18.2, offering a more personalized approach to cancer treatment. In the zolbetuximab Phase 3 clinical trials, approximately 38% of adult patients with advanced and metastatic gastric and GEJ cancers had tumors that were CLDN18.2 positive. By binding to CLDN18.2 expressed on tumor cell membranes, zolbetuximab results in antibody- dependent cellular cytotoxicity, complement dependent cytotoxicity and tumor growth inhibition. Data from the Phase 3 SPOTLIGHT and GLOW clinical trials, which supported the European Marketing Authorization, showed that treatment with zolbetuximab provided statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers. In the SPOTLIGHT trial, a median PFS of 10.61 months was achieved with zolbetuximab plus mFOLFOX6 as first-line treatment, versus 8.67 months with placebo plus mFOLFOX6. The median OS was 18.23 months versus 15.54 months in the respective treatment groups. Similar efficacy findings were seen in the GLOW trial where median PFS was 8.21 months versus 6.80 months, and median OS 14.39 months versus 12.16 months, with zolbetuximab plus CAPOX, compared to placebo plus CAPOX, respectively. In both the SPOTLIGHT and GLOW trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite. The European Marketing Authorization for zolbetuximab is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and is aligned to the recently updated ESMO Gastric Cancer Living Guidelines which state that the addition of zolbetuximab to chemotherapy can be considered for patients with CLDN18.2 positive, HER-2 negative tumors in the first-line metastatic disease setting. Astellas is working closely with local regulatory authorities and health technology assessment bodies across the EU to ensure that patients who may gain benefit from zolbetuximab are able to access the novel treatment as soon as possible. This regulatory approval for zolbetuximab follows the August 2024 approval by the UK Medicines and Healthcare products Regulatory Agency and the March 2024 approval by Japan's Ministry of Health, Labour and Welfare. Astellas has submitted further applications for zolbetuximab to other regulatory agencies around the world with reviews ongoing.

Astellas Pharma Inc. Presents at DPHARM US 2024, Sep-17-2024 . Venue: Philadelphia, PA, Philadelphia, Pennsylvania, United States. Speakers: Mohammed Ali, R&D Head of Business Performance & Analytics, CMO Office.

Astellas Pharma Inc. - Analyst/Investor Day

Astellas Pharma Inc. has announced a Fixed-Income Offering in the amount of ¥80 billion. Security Name: 0.87% Unsecured Notes due September 07, 2029 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: ¥80 billion Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Astellas Pharma Inc. announced that VEOZAH™? (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, will be featured in four oral presentations during the 2024 Annual Meeting of The Menopause Society (TMS) September 10-14 in Chicago. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause. Fezolinetant data to be presented during the 2024 Annual meeting of The Menopause Society include: Two separate pooled analyses from SKYLIGHT 1 and SKYLIGHT 2 examining improvements in patient-reported sleep disturbance and impairment (Session 1; Sept. 12, 4:30-4:45 p.m.; Marla Shapiro, C.M.), as well as the relationship between improvements in the frequency or severity of hot flashes and mood (Top ScoringAbstract Session; Sept. 13, 1-1:15 p.m.; Genevieve Neal-Perry, M.D.). Data from DAYLIGHT evaluating% reduction (50%, 75% and 100%) in frequency of moderate to severe VMS in women considered unsuitable for hormone therapy (Session 2; Sept. 12.45-6 p.m.; Marla SPiro, C.M.). Pooled data from SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4 assessing the safety and efficacy of fezolinetant in Hispanic and Latina participants (Session 1; Sept. 12, 4:45-5 p.m.; Genevieves Neal-Perry, M.'D.). An additional poster presentation will highlight results of a qualitative analysis designed to identify concepts and perspectives related to VMS experience among Black or African American women (Thursday, Sept. 12, 6:15-7:15 p.m.; Makeba Williams, M.D.). Stop VEOZAH and call healthcare provider right away if have the following signs or symptoms of liver problems: feeling more tired than do usually; nausea; vomiting; itching; yellowing of the eyes or skin (jaundice); pale diarrhea; dark urine; pain in the right upper stomach (abdomen). The most common side effects of VEOZAH include: stomach (abdominal) pain; diarrhea; diarrhea; difficulty sleeping (insomnia) back pain; hot flashes or hot flushes. These are not all the possible side effects of VEOZah.

Astellas Pharma Inc. Presents at ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit, Sep-09-2024 . Venue: Revere Boston, 200 Stuart Street, Boston, Massachusetts, United States. Speakers: Masashi Shimazaki, Senior Director, PF-TPD Portfolio Strategy Lead, Natalia Ulyanova, Business Development Director, Oncology.

Hanson Wade Limited, ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit, Sep 09, 2024 through Sep 10, 2024. Venue: Revere Boston, 200 Stuart Street, Boston, Massachusetts, United States.

Shin Nippon Biomedical Laboratories, Ltd. announced that it will collaborate with Astellas Pharma Inc. (hereinafter referred to as Astellas) to strengthen the drug discovery ecosystem in Tsukuba, by providing non-clinical studies at a facility adjacent to SakuLab-Tsukuba, an open innovation center in the Tsukuba Research Center of Astellas. SakuLab-Tsukuba is located in Tsukuba, Japan, where one of Japan's leading life science centers is being formed. It is an open innovation lab that welcomes innovators from outside the company, including startups and academia. Resident researchers have access to ready-to-use lab equipment and non-confidential consultation on a wide range of drug discovery research activities and networking opportunities with Astellas' scientists. SNBL, with its mainstay CRO (Contract Research Organization) business, conducts nonclinical and clinical studies (clinical trials) for drug development on behalf of pharmaceutical companies and academia. SNBL supports the concept of SakuLab-Tsukuba and will participate to enhance the life science ecosystem as the largest nonclinical CRO in Japan. Leveraging its experience and track record in drug discovery across various modalities, SNBL will support tenants of SakuLab-Tsukuba, Astellas, as well as other pharmaceutical companies and bio-ventures in a wide range of nonclinical studies, including physical properties, pharmacology, kinetics, and safety assessments in the early stages of drug development. SNBL, with its corporate mission of "freeing people from suffering," will continue to support the research and development of advanced technologies in the life science field and businesses that aim to apply and improve technologies in the medical field.

Astellas Pharma Inc. announced that the European Commission has granted Marketing Authorization for PADCEV (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy. The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy. Bladder cancer is the fifth most commonly diagnosed cancer across the European region. Every year, more than 165,000 people are diagnosed with the disease and it claims the lives of over 50,000 people in the European Union (EU). Diagnosis often comes late, with many patients presenting with advanced or metastatic disease where survival outcomes are particularly poor. The Phase 3 EV-302 clinical trial explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). The median PFS of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice. Results were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine. The European Marketing Authorization is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and is aligned to recently updated clinical guidelines from the European Society for Medical Oncology and European Association of Urology which recommend enfortumab vedotin in combination with pembrolizumab as first-line treatment for locally advanced or metastatic urothelial cancer. Astellas is working closely with local regulatory authorities and health technology assessment bodies across the EU to ensure that patients who may gain benefit are able to access the treatment combination as soon as possible. The approval follows the December 2023 approval of enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with la/mUC by the U.S. Food and Drug Administration (FDA), and the European Commission approval of enfortumab vedotin as a monotherapy for the treatment of adult patients with la/mUC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in April 2022. Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025. EV-302 is an ongoing, open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The trial enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety. The most common (=3%) Grade 3 or higher adverse events related to treatment with enfortumab vedotin and pembrolizumab were maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. The safety results in EV-302 are consistent with those previously reported with this combination in EV-103 in cisplatin-ineligible patients with la/mUC. No new safety issues were identified. The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and were published in the New England Journal of Medicine.

Astellas Pharma Inc. announced dosing of the first patient in the HIGHLIGHT 1™ Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies, most commonly tamoxifen and aromatase inhibitors, and up to 97% of breast cancer patients experience hot flashes or night sweats. HIGHLIGHT 1 is a randomized, placebo-controlled, double-blind, Phase 3 clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites globally. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks. Fezolinetant is an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.